The project ‘NSCLC Diagnostics - Algorithm’ (DiaNA) by prof. dr hab. Natalia Marek-Trzonkowska from the International Centre for Cancer Vaccine Science has been recommended by the Agency for Medical Research for funding of nearly PLN 15 million. The initiative aims to develop and validate new diagnostic methods for non-small cell lung cancer that will be highly accessible and effective in the early detection of the cancer.
Lung cancer is the most common cause of death in oncology patients of both sexes. Non-small cell lung cancer (NSCLC) accounts for 85% of cases. NSCLC is a major problem for the health care system, as the risk group is as many as 3 million people for whom optimal screening diagnosis is still lacking. The low-dose CT scan used today is characterised by a high false-positive rate, low efficiency in the diagnosis of small nodules (<1cm) and limited availability. The aim of the DiaNA project is to provide two new diagnostic methods for NSCLC that will enable widespread and effective screening. The methods under development involve using only a blood sample and simplifying the analysis of diagnostic test results using machine learning techniques so that their interpretation does not require the involvement of advanced medical personnel.
The project is based on preliminary results obtained by the International Centre for Cancer Vaccine Science (ICCVS) team under the direction of prof. Natalia Marek-Trzonkowska, DiaNA project manager, during previous R&D projects. The ICCVS team has developed two methods to identify patients with early-stage NSCLC based on a blood test. Preliminary studies indicate a high specificity of the identified markers and the diagnostic algorithm. The DiaNA project plans to validate the discovered markers in a study involving more than 2,000 cancer patients and healthy volunteers.
‘The diagnostic methods we have developed, which we will develop in the DiaNA project, are the result of close cooperation in our team of researchers working in the field of cancer immunology, flow cytometry, mass spectrometry and bioinformatics,’ says prof. dr hab. Natalia Marek-Trzonkowska. ‘At this point, I would like to express my sincere thanks to the people who contributed to the preliminary results of the project, as well as supported its construction from the administrative side: dr Sachin Kote, dr Artur Piróg, dr Ines Papak, dr Jakub Faktor, dr Monikaben Padariya, dr Anna Biernacka, dr Zuzanna Urban-Wójciuk, dr Martyna Muszczek, dr Katarzyna Dziubek, as well as Izabela Raszczyk and Dominika Butkiewicz. The project and its preliminary results would also not have been possible without good cooperation with the team from the Department of Chest Surgery at the Medical University of Gdańsk, led by prof. dr hab. Witold Rzyman. The multidisciplinary nature of ICCVS has allowed us to approach lung cancer diagnosis in a completely new way. We hope that our research will change the diagnosis of NSCLC, making it simple and accessible.’
The first method developed uses a blood sample that is analysed with flow cytometry. The flow cytometer is now standard equipment in clinical immunology laboratories, so its availability is not a limiting factor in the method's application. Researchers have developed a panel of 16 antibodies to characterise selected natural killer (NK) cell populations. NK cells are known for their anticancer activity. In parallel, an analytical algorithm has been developed that reduces the results obtained to a graphical formula. Reading the result only requires applying the template and assessing whether the result falls within its limits.
‘The procedure takes less than a minute and requires no specialist knowledge,’ adds prof. Natalia Marek-Trzonkowska. ‘At this point, I would like to mention that we have observed that the diagnostic pattern is different for women and men. This diagnostic therefore also takes into account the factor of the sex of the person being tested.’
The second method also uses a blood sample, which is analysed using a mass spectrometer. ‘In our earlier studies, we identified approximately 7,000 peptides presented by MHC class I NSCLC molecules, but not by healthy lung cells (so-called neoantigens), explains prof. N. Marek-Trzonkowska. - Subsequently, we observed that 4 of them were also present in the blood of NSCLC patients. Interestingly, we detected them in all the patients' blood samples we tested, but never in samples from healthy individuals. The DiaNA project will enable us to validate the diagnostic value of the discovered neoantigens and further develop the method for simplification.’
The methods planned for development in the project have a high potential for implementation and commercialisation. In both cases, the test material is blood, which will ensure widespread availability of the test.
‘The DiaNA project is another project with commercialisation potential, which increases the portfolio of application projects underway at ICCVS and contributes to our strategic plans,’ adds Izabela Raszczyk, MBS, ICCVS director of administration.
Both methods have a great potential for implementation due to the type of test material and the rapid interpretation of the results, and thus bring a great opportunity to improve the health of the population.
The implementation of the DiaNA project will take place thanks to funding from the Medical Research Agency within the framework of the competition for scientific entities to carry out applied research in the biomedical area (2024/ABM/03/KPO) under the National Plan for Rehabilitation and Enhancement of Immunity (KPO), Component D: Efficiency, accessibility and quality of the health system, Investment D3.1.1: Comprehensive development of research in medical and health sciences. 224 applications were submitted in the competition, and 57 projects were recommended for support, for a total amount of PLN 446,529,261.37.
The project ‘NSCLC Diagnostics - Algorithm’ (DiaNA) by prof. dr hab. Natalia Marek-Trzonkowska was recommended by the Medical Research Agency for support in the amount of PLN 14,896,000.
For more information and a ranking list of evaluated projects: https://abm.gov.pl/pl/aktualnosci/2956,Kolejny-wazny-krok-w-realizacji-Krajowego-Planu-Odbudowy-w-obszarze-badan-z-zakr.html.
For more information on research conducted at the International Centre for Cancer Vaccine Science: https://iccvs.ug.edu.pl
